FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
OXY-TWO
K Number: K852624
·
Decision Sep 18, 1985
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
12
Review Days
90
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Basic Information
- Device Name
- OXY-TWO
- K Number
- K852624
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ashai Co. , Ltd.
- Date Received
- June 20, 1985
- Decision Date
- September 18, 1985
- Product Code
- BYG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.
FIRST AID KIT(S)
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HANS RUDOLPH NASAL CPAP MASK
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DISPOSABLE, CPAP OXYGEN MASK
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WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
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VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
FDA 510(k)
FDA Class 1
·Anesthesiology
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Ashai Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K870428 | AEROSOL ONE, NEBULIZER PUMP | May 15, 1987 | Substantially Equivalent |
| K852622 | AEROSOL ONE | Apr 24, 1986 | Substantially Equivalent |
| K852620 | SAFE.N.SURE | Oct 31, 1985 | Substantially Equivalent |
| K852627 | MAXI-NEB | Sep 26, 1985 | Substantially Equivalent |
| K852628 | NASAL ONE | Sep 18, 1985 | Substantially Equivalent |
| K852625 | OXY-TUBE | Sep 18, 1985 | Substantially Equivalent |
| K852629 | AERO-MASK TWO | Sep 18, 1985 | Substantially Equivalent |
| K852618 | OXY-DIAL | Sep 18, 1985 | Substantially Equivalent |
| K852626 | AERO-MASK ONE | Sep 18, 1985 | Substantially Equivalent |
| K852623 | OXY-ONE | Sep 18, 1985 | Substantially Equivalent |